Yu Ke-Na, Ni Zhao-Hui, Wang Nian-Song, Peng Wen, Wang Yi, Zhang Chang-Ming, He Li-Qun
Department of Nephrology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China.
Department of Nephrology, Renji Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200021, China.
Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2016 Dec 20;38(6):686-695. doi: 10.3881/j.issn.1000-503X.2016.06.010.
Objective To evaluate the clinical effectiveness of JianpiQinghua decoction in treating stage 3 chronic kidney disease (CKD3) with syndrome type of dampness-heat due to spleen deficiency. Methods A multicenter, randomized, controlled, prospective, double-blind, and double-simulation study was undertaken. A total of 270 CKD3 patients with syndrome type of dampness-heat due to spleen deficiency from the outpatient departments of six general hospitals were randomly divided into telmisartan+analog traditional Chinese medicine (TA) group, traditional Chinese medicine+analog telmisartan (TCMA) group, and telmisartan+traditional Chinese medicine (TTCM) group, in which the corresponding treatment was applied in addition to basic treatment. Six months later, changes in the traditional Chinese medicine (TCM) clinical symptom scores and renal functions before and after treatment were compared among these three groups. Results Of these 270 CKD3 patients who had been enrolled in this study, 30 cases lost to follow-up. The baseline data were comparable among these three groups. After treatment, the TCM clinical symptom scores of both syndrome of spleen-qi deficiency and dampness-heat in TA group were significantly higher than those in TCMA group and TTCM group (P<0.001). With the treatment time prolonged, the TCM clinical symptom scores showed similar descending trends in TCMA group and TTCM group but were different from that in TA group. After treatment, abnormal creatinine rate decreased (P=0.003), and these three treatments and their interactions with each visit had no effect on serum urea nitrogen value (P=0.270, P=0.520); with prolonged treatment, the estimated glomerular filtration rates in three groups tended to be relatively stable after the first rise. The liver function and abnormal serum potassium rate were not statistically significant before and after treatment (P>0.05). Conclusions JianpiQinghua decoction can improve clinical symptoms of TCM in CKD3 patients with syndrome type of dampness-heat due to spleen deficiency and thus improve the quality of life and prognosis. The clinical efficacy of JianpiQinghua decoction alone or combined with telmisartan is superior to telmisartan monotherapy.
目的 评价健脾清化方治疗脾虚湿热型3期慢性肾脏病（CKD3）的临床疗效。方法 采用多中心、随机、对照、前瞻性、双盲、双模拟研究。选取6所综合医院门诊的270例脾虚湿热型CKD3患者，随机分为替米沙坦+模拟中药（TA）组、中药+模拟替米沙坦（TCMA）组、替米沙坦+中药（TTCM）组，在基础治疗的基础上分别给予相应治疗。6个月后，比较三组治疗前后中医临床症状评分及肾功能变化。结果 本研究纳入的270例CKD3患者中，30例失访。三组基线资料具有可比性。治疗后，TA组脾气虚证和湿热证的中医临床症状评分均显著高于TCMA组和TTCM组（P<0.001）。随着治疗时间延长，TCMA组和TTCM组中医临床症状评分呈相似的下降趋势，但与TA组不同。治疗后，血肌酐异常率下降（P=0.003），三种治疗方法及其与每次就诊的交互作用对血清尿素氮值无影响（P=0.270，P=0.520）；随着治疗时间延长，三组的估计肾小球滤过率在首次升高后趋于相对稳定。治疗前后肝功能及血钾异常率差异无统计学意义（P>0.05）。结论 健脾清化方可改善脾虚湿热型CKD3患者的中医临床症状，从而提高生活质量和预后。健脾清化方单独或联合替米沙坦的临床疗效优于替米沙坦单药治疗。
